FDA 510(k) Application Details - K232567

Device Classification Name	More FDA Info for this Device
510(K) Number	K232567
Device Name	Myriad SPECTRA Light Source
Applicant	NICO Corporation 250 East 96th Street, Suite 125 Indianapolis, IN 46240 US Other 510(k) Applications for this Company
Contact	Megan Becker Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QFX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/24/2023
Decision Date	03/14/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review